Summary: The
strategic plan for NIH National Center
for Complementary and
Alternative Medicine showed steps toward clarification at the February 5, 2010 meeting of the National Advisory
Council. This report from Integrator columnist Taylor Walsh share's the agency's directions, plus a list of the 5 new
appointees. The range of initiatives is wide, from reductive approaches to products to engaging lifestyle-change initiatives and mind-body interventions. Council member Janet Kahn, PhD reviewed Walsh's article and offers additional perspectives on the direction. Kahn calls to the practitioner community that is interested in "real world research" to utilize NCCAM's existing health services research initiative.

Send your comments to
This email address is being protected from spam bots, you need Javascript enabled to view it
for inclusion in a future Integrator.

Notes from the Advisory Council Meeting:
NCCAM's Growing Clarity on Strategic Plan

The National Advisory Council
of NCCAM gathered in the hours
just prior to the beginning of "Blizzard Week" in the mid-Atlantic
region.
(We'll be digging out deep into March). Their agenda included
discussing and approving the new
structure and focus for NCCAM research going forward and to review the
progress
of, and public commentary on, NCCAM's new strategic plan.
Several themes that have been percolating within NCCAM were
reinforced during the meeting:

NCCAM
is organizing its research to address high profile health issues that
have
become serious factors in national health policy, notably lifestyle
change
initiatives and pain management.

Continued
emphasis on research that attempts to identify the biological
mechanisms
involved in CAM therapies.

A more
open approach to mind-body therapies appears to have been elevated in a
way that gives NCCAM's historical work in the area a distinctive
position
at a time when the factors that influence behavior-change are high on
the
national lifestyle agenda.

The
strategic plan is due to be
completed in August,
according
to NCCAM director Briggs.

The most significant aspect of the meeting
could well be the
composition of the council itself, with the addition of five new
members. In the last 12 months, the complexion has
changed substantially. Of the 18 members called for in the enabling
legislation, 5 are
now from the licensed CAM fields: two licensed acupuncturists, a
chiropractic doctor, a naturopathic physician and a massage therapist.
The new face of the advisory council could be particularly
important as NCCAM is in the middle of preparing its Five Year
Strategic Plan. The plan is due to be completed in August, according to
NCCAM director Josephine
Briggs, MD. The participation of these new
council members adds a broader and deeper level of experience with the
practicalities of integrative practice, even including the evolution of
its
position in the health reform legislation.
New council members include:

Susan Folkman, PhD, professor
emeritus
in the Dept. of Medicine at USCF where she was also the founding
director
of the Osher Center for Integrative
Medicine and co-director of the UCSF
Center for AIDS Prevention Studies.
She was a member of the Institute of Medicine panel on CAM use in
the US and served as chair of CAHCIM.

Steven
T. deKoskey, MD, vice
president at the University of Virginia and dean of the School of
Medicine. He was director of the NCCAM-funded national multi-center
trial
to assess the potential of Ginkgo bilboa to delay onset of dementia.
His basic research centers on structural
and neurochemical changes in the human brain in normal aging and
dementia.

Gary Curhan,
MD, ScD, associate
professor of medicine at Harvard Medical School, and at its School of
Public Health. He is a practicing
nephrologist and is internationally recognized for his work in
population
epidemiology and the epidemiology of kidney disease, with NIH-funded
over
the last 15 years.

Janet Kahn, PhD, executive
director of the Integrated
Healthcare Policy Consortium (IHPC) and
assistant professor in the Dept. of Psychiatry at the University of
Vermont. She is also a faculty
preceptor in the Fellowship in Complementary and Alternative and
General
Medicine at Harvard Medical School.
Dr. Kahn has been a massage therapist for 30 years and has recently
focused research on its applications for chronic pain.

"The
structure [for NCCAM's funding plan] was
presented in
the shape of a funnel by which
selected proposals will be winnowed
through
Mechanistic
and Early-Phase
Clinical studies."

The most intriguing appointment is
perhaps that of Janet
Kahn, who through IHPC has been deeply involved in the health care
reform
legislative processes, much of which has been reported here in the
Integrator. The complete NACCAM roster
is here and the NCCAM release on the appointments is here.
The council members heard presentations from NCCAM staff
that described the new process though which research proposals must
pass. The structure was presented in
the shape of a funnel by which selected proposals will be winnowed
through Mechanistic
and Early-Phase
Clinical studies, a process that is intended to identify the
most
promising, and most expensive, large-scale studies.
The mechanistic studies will largely focus on natural
products (isolated and multi-component plant, animal, microbial,
probiotics)
and are intended to "develop hypotheses in a range of clinical
indications" by
focusing on questions such as:

What is the bio signature of the response?

The genetic pathway of the receptor cell?

The function of the organism?

In explaining the emphasis on these studies, director Briggs
said, "NCCAM previously focused on complexity, and (as a result) lost
the
mechanistic information that is valuable.
For instance: if echinacea affects colds, do you have the information"
as to how that happens?
"Traditional Chinese herbal mixtures," she noted, "are used
in a broad range that doesn't map well with western medicine. NCCAM
support has not produced much of
promise ... There will be better understanding with biomarkers."
Deputy Director Jack Killen said: "Without a biological
understanding -- in a controlled trial that shows ‘no effect' (but)
without
insight into the biology -- you have nothing. It is a pervasive problem
in this field."

"This
approach, described as 'filling in the
gaps,' is
clearly meant to address the
strongest strains of criticism from
conventional
medicine."

This approach, described as "filling in the
gaps," is
clearly meant to address the strongest strains of criticism from
conventional
medicine. Last December, NCCAM
celebrated its 10th anniversary in part by holding a
daylong "Research Symposium: Exploring the Science
of Complementary and Alternative Medicine" that focused heavily on
the
mechanisms of natural products.
Several council members raised cautions about biomarkers as
kinds of endpoints. "Medicinal cure is
not the issue," said Steven Barnes, of the University of Alabama.
"Disease management can always make (patient
experience) better. We don't always want
to be judged on cures."
New member Steven DeKovsky (director of NCCAM's recent
Gingko bilboa study) agreed: "If the target is cure, we'll have
trouble. In symptom relief, decline would be a goal
good enough for the next horizon."

Several
council members raised
cautions about
bio-markers
as
kinds of endpoints.

New member Susan Folkman questioned to what
degree the
mechanistic approach might understate the full measure of a treatment's
benefit.
These and other comments during the meeting underscored a
kind of embrace by NCCAM of the historic tensions with which it has
always had
to deal. Briggs showed a slide with a
remark by former council member Ted J. Kaptchuk from a recent issue of Lancet:

"There
is a fundamental human tension between exuberant belief and rational
skepticism."

While Briggs repeatedly reinforced the importance of
defining the biomarkers, she also hinted that NCCAM might move along
new
research paths that have been defined by the Comparative Effectiveness
Research
(CER) program that was set out earlier this year by the Institute of
Medicine. That program gives observational
studies a new level of credibility, reflecting the belief that decision
makers
need broader definitions of "real world" evidence.
Discussing NCCAM's efficacy studies, Briggs said, "Double
blind random controlled trials for pharma and natural products are
absolutely
the gold standard. But that doesn't work
in mind body. You can't have sham
meditation." Noting the increasingly
strong mind-body expertise now part of its advisory council, she added
tantalizingly that NCCAM "has to lead the NIH in this area."

"Noting the increasingly
strong
mind-body expertise now part
of its advisory council, she added
tantalizingly that NCCAM 'has to
lead the NIH in this area.'"

Elsewhere inside NIH other initiatives are
responding to a
rapidly changing health marketplace in which lifestyle improvement is
quickly
rising to a level of equivalence with disease management on the
national
attention scale, and in which prevention strategies are finding
increasing
appeal. NCCAM
could play a significant role coordinating research initiatives that
will apply
mind-body approaches that are led by other NIH entities."
Reflecting this focus and potential, the next Advisory
Council Meeting in June will focus primarily on "The Science of
Behavior
Change." In April, a workgroup in the
strategic planning process will focus on Mind-Body approaches.The Strategic Plan
Briggs reported that NCCAM received 400 comments and
recommendations in response to the three papers it made available for
public
comment at the end of last year. She
addressed the responses in terms of "concerns" and ‘areas of support,"
noting a
"certain polarization in the comments."
Concerns:

NCCAM
has delivered no cures

A lack
of real evidence

NCCAM
is an advocate for CAM therapies

Support and recommendations:

Focus
on product integrity

Distinguish
between symptom management and cures

Focus
on healthy behaviors

Basic
and translational research

Real
world outcomes

Although Briggs' specific commentary on the plan was
somewhat sparse, she said that NCCAM has to "position ourselves as
objective
and neutral" and focus efforts where the greatest public impact will be
felt.
In addition to the mind-body workshop at the end of April,
the planning group will hold workshop in March on natural products, and
in May
on "Deconstructing Back Pain."

______________________________

Comments from Council Member Janet Kahn,
PhD

Council member Janet Kahn, PhD

Janet Kahn, PhD has
just begun her second term on the National Advisory Council for NCCAM.
Her first was when NCCAM began operating in 1999. Informing Kahn's
research is 30 years of practice as a massage therapist. Kahn also
serves, as Walsh notes, as executive director of the Integrated
Healthcare Policy Consortium. I asked Kahn to review Walsh's article
and comment. She thought that Walsh's report generally captured the
content of the NACCAM public meeting then added these comments.

Regarding the "filling the gaps" strategy:
"I think this is an important prioritization
process. In its early years, NCCAM spent
millions of dollars on large
botanical trials that indicated no significant effect of the herbs.
While
in research we always acknowledge that negative findings are as
important as
positive findings, this is only true (in either case) if you trust the
findings and a number of those early studies were roundly criticized.
For
example, the 2002 study on St. John’s Wort for depression found it to
be no
more effective than placebo. But the trial was for major depression and
the
public in general was taking St. John’s Wort for minor depressive
symptoms. So
one could argue that a lot of money was spent that did not answer the
more
pressing public health question. This winnowing process that Dr. Briggs and her staff described at the meeting is planned to
help NCCAM spend its available budget wisely. It is not meant to
identify
the most expensive large-scale trials. It is meant to identify the most
promising trials by making sure we know before we start what the
presumed
mechanism of action is so that the protocol is designed to test that and
the
control group reflects what we know about who is actually using it as well as who will be most likely to respond to the treatment. Large
trials are an enormously expensive form of research and
these decisions should be made with enough preliminary data from small studies and mechanism investigations to be sure
we will
not be full of “if onlies” when the findings come in."

"Most if not all Council members
and NCCAM staff
agree that
[real world research] is
an important area to fund."

Regarding "real world" studies: "NCCAM
has had an initiative since 2008 that called for
Health Services Research. The initiative is PAR-08-045: Outcomes,
Cost-effectiveness and the Decision Process to Use CAM. It had 3
submission dates, May 2008, 2009, & 2010. So the May 2010 date is
still possible for folks. Historically very
few applications have been submitted. In 2008, 1 was
funded. (Lafferty on CAM Medical Service Utilization and Quality of
Care). In
2009 again few came in and only a minority of them got scores that would put them within the normal
NCCAM
pay-line for this year. Most if not all Council members and NCCAM staff agree this is an important area to fund.
NCCAMs payline is tough because of our small budget."

Kahn then added two more key points, plus one:

Importance of health services "The
NCCAM staff and council are in agreement about the importance of this
issue
and are seeking good proposals to fund. It will not serve to fund
proposals
that are not up to snuff b/c that will only add fuel to detractors from
all
sides while not adding anything helpful and reliable to our wisdom
pool."

Challenges of "real world" settings "It
isn't easy or cheap to do studies that occur in a variety of settings
with
protocols that vary by person. It is incumbent upon the CAM research
community to create/locate/appropriately tailor the research methods
required
to answer the questions about use in these contexts. If NCCAM had
received 80 proposals and had the same ratio of good ones, more would
be
funded. You can't win if you don't play."

About the research methods and her own
background "I find in Dr. Briggs someone with real appreciation of
this problem
and a greater knowledge of and respect for a range of research
methodology, including observational, longitudinal, and multiple forms
of
qualitative research. Personally, after an early career at the
American Institutes for Research during which I did largely survey and
program
evaluation research, I went to Brandeis for my doctorate in sociology
focusing
on medical sociology and qualitative research methods. I knew I was tired of the
quantitative
trap of having my questions framed by what could be answered using the
research
methods at hand even when it meant ignoring the most compelling
questions,
but I wasn't sure if there was really any rigor to qualitative
methodology. After more years getting that doctorate than I should
have
spent there, I can say that there is rigor, but it isn't always
applied.
If the plural of anecdote is not data, it is comparably true that the
formal term
for well-written opinion is not qualitative research - method matters."

If the real world does not fit
leading methodologies, it is not the real world that should be tossed. It's the methodologies.

If the real world does not fit leading
methodologies, it is not the real world that should be tossed; it's the methodologies. While this arena is certainly complex, so is the typical
healthcare interaction. Researchers, partner with integrative clinicians. Go figure it out! Get on it! NCCAM: Support them. Promote it.
The tension noted by Briggs is less between Kaptchuk's
"exuberant belief" and
"rational skepticism" than it is between actual practice and make-believe. Or
rather, as has unfortunately been the outcome of NCCAM's past reductive agenda, make
disbelief. Hopefully in these next 6 months NCCAM will acknowledge that what these stakeholders request should be a
significant part of the 2011-2015 strategic plan. How about a future NACCAM
meeting that focuses on training and methodology issues in these areas? Both reviewers and researchers who want to examine whole practices could benefit from ongoing training and exchange of ideas. NCCAM could serve the community, and health care, by taking a leading role in finding winning strategies to evaluate these complex interactions.

By doing so, NCCAM will serve other aspects of its emerging agenda as noted by Walsh. Namely, such a focus will prepare the integrative practice research community for more effective participation in related lifestyle, behavioral health, comparative effectiveness and mind-body research initiatives.

Send your comments to
This email address is being protected from spam bots, you need Javascript enabled to view it
for inclusion in a future Integrator.